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CTRI Number  CTRI/2024/10/075653 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   comparison of the safety and effictiveness of three different approaches to pain relief after spine surgery 
Scientific Title of Study   Comparative safety and efficacy of three different ultrasound guided approaches to lumbar dorsal rami for pain relief in adults undergoing lumbar spine surgery – a double blind randomized controlled non-inferiority trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parnandi Bhaskar Rao 
Designation  Professor 
Affiliation  All India Institute of medical sciences, Bhubaneswar 
Address  ROOM NO. 426, 4TH FLOOR, ACADEMIC BUILDING, AIIMS, SIJUA, PATRAPADA, BHUBANESWAR

Khordha
ORISSA
751019
India 
Phone  09438884044  
Fax    
Email  anaes_bhaskar@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Parnandi Bhaskar Rao 
Designation  Professor 
Affiliation  All India Institute of medical sciences, Bhubaneswar 
Address  ROOM NO. 426, 4TH FLOOR, ACADEMIC BUILDING, AIIMS, SIJUA, PATRAPADA, BHUBANESWAR

Khordha
ORISSA
751019
India 
Phone  09438884044  
Fax    
Email  anaes_bhaskar@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Parnandi Bhaskar Rao 
Designation  Professor 
Affiliation  All India Institute of medical sciences, Bhubaneswar 
Address  ROOM NO. 426, 4TH FLOOR, ACADEMIC BUILDING, AIIMS, SIJUA, PATRAPADA, BHUBANESWAR

Khordha
ORISSA
751019
India 
Phone  09438884044  
Fax    
Email  anaes_bhaskar@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  Parnandi Bhaskar Rao 
Address  Room No. 426, 4TH Floor, Academic Building, AIIMS, Sijua, Patrapada, BHUBANESWAR, PIN 751019, Orissa, India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NITASHA MISHRA  ROOM NO. 12, 5TH FLOOR, HOSPITAL BUILDING, AIIMS, SIJUA, PATRAPADA, BHUBANESWAR 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parnandi Bhaskar Rao  Orthopaedics Operation Theatre  4TH FLOOR, S4+2, HOSPITAL BUILDING, AIIMS, SIJUA, PATRAPADA, BHUBANESWAR
Khordha
ORISSA 		 09438884044

anaes_bhaskar@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhubaneswar ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M479||Spondylosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control  no block but shall receive standard analgesics for pain relief 
Intervention  three different approaches to lumbar dorsal rami block  erector spinae plane block thoracolumbar interfascial plane block submultifidus block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult ASA 1 & 2 patients undergoing lumbar spine surgery up to 4 levels with midline incision in prone position 
 
ExclusionCriteria 
Details  Those who refuse to participate
Sensitive to local anaesthetics
Liver and Kidney failure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
time from block administration to demand of first analgesia by patient after surgery  at 0, 4 and 12 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Total tramadol consumption within 24 hours after surgery

Postoperative pain score (VAS)

Quality of Recovery – 9 score

Any block related complications
 		 at 0, 6, 12 and 24 hours after surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Lumbar spine surgery is often associated with severe pain in the perioperative period. Several regional analgesia techniques have been found to be effective in the management of pain in these group of patients [1]. Erector spinae plane block (ESPB) and thoracolumbar interfascial plane block (TLIP) are established regional approaches for effective pain management with reduction in pain scores and opioid consumption [2, 3]. Similarly, lumbar submultifidus muscle block has been introduced recently as a novel regional analgesia technique. This involves instillation of local anaesthetics below the lumbar multifidus muscle to block pain conduction through dorsal rami providing acceptable analgesia following lumbar spine surgery [4].
 However, scarce information is available on the comparative safety and efficacy of these approaches for post-operative analgesia for lumbar spine surgery, hence we planned this randomized controlled trial.  
REFERENCES:

1.      Hong B, Baek S, Kang H, Oh C, Jo Y, Lee S, Park S. Regional analgesia techniques for lumbar spine surgery: a frequentist network meta-analysis. Int J Surg. 2023 Jun 1;109(6):1728-1741.

2.      Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647.

3.      Abdildin YG, Salamat A, Omarov T, Sultanova M, Krassavina Y, Viderman D. Thoracolumbar Interfascial Plane Block in Spinal Surgery: A Systematic Review with Meta-Analysis. World Neurosurg. 2023 Jun;174:52-61.

4.      Song L, Ying S, Wang Z, Yuan X. Ultrasound-guided lumbar multifidus block provides effective postoperative analgesia for lumbar spine surgery. J Clin Anesth. 2018 May;46:116-117.

 
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